|Publication number||US20050154425 A1|
|Application number||US 10/921,757|
|Publication date||Jul 14, 2005|
|Filing date||Aug 19, 2004|
|Priority date||Aug 19, 2004|
|Publication number||10921757, 921757, US 2005/0154425 A1, US 2005/154425 A1, US 20050154425 A1, US 20050154425A1, US 2005154425 A1, US 2005154425A1, US-A1-20050154425, US-A1-2005154425, US2005/0154425A1, US2005/154425A1, US20050154425 A1, US20050154425A1, US2005154425 A1, US2005154425A1|
|Inventors||Birinder Boveja, Angely Widhany|
|Original Assignee||Boveja Birinder R., Angely Widhany|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (4), Referenced by (41), Classifications (8)|
|External Links: USPTO, USPTO Assignment, Espacenet|
This invention relates to providing electrical and magnetic pulses to the body, more specifically using combination of gradient magnetic pulses (GMP) to the brain, and pulsed electrical stimulation to vagus nerve(s) to provide therapy for neuropsychiatric disorders, and cognitive impairments.
This disclosure is directed to method and system for providing adjunct (add-on) therapy for neuropsychiatric disorders and cognitive impairments, including depression, bipolar depression, anxiety disorders, obsessive-compulsive disorders, schizophrenia, borderline personality disorders, sleep disorders, learning difficulties, memory impairments and the like. The method and system comprises using combination of gradient magnetic pulses (GMP) to the brain and providing pulsed electrical stimulation to the vagus nerve(s) (VNS), to provide therapy. GMP and VNS may be used in combination to drug therapy, or as an alternative to drug therapy. The combination use of GMP and VNS is shown in conjunction with
Depression is a very common disorder that is often chronic or recurrent in nature. It is associated with significant adverse consequences for the patient, patient's family, and society. Among the consequences of depression are functional impairment, impaired family and social relationships, increased mortality from suicide and comorbid medical disorders, and patient and societal financial burdens. Depression is the fourth leading cause of worldwide disability and is expected to become the second leading cause by 2020.
Among the currently available treatment modalities include, pharmacotherapy with antidepressant drugs (ADDs), specific forms of psychotherapy, and electroconvulsive therapy (ECT). ADDs are the usual first line treatment for depression. Commonly the initial drug selected is a selective serotonin reuptake inhibitor (SSRI) such as fluoxetine (Prozac), or another of the newer ADDs such as venlafaxine (Effexor).
Several forms of psychotherapy are used to treat depression. Among these, there is good evidence for the efficacy of cognitive behavior therapy and interpersonal therapy, but these treatments are used less often than are ADDs. Phototherapy is an additional treatment option that may be appropriate monotherapy for mild cases of depression that exhibit a marked seasonal pattern.
Many patients do not respond to initial antidepressant treatment. Furthermore, many treatments used for patients who do not respond at all, or only respond partially to the first or second attempt at antidepressant therapy are poorly tolerated and/or are associated with significant toxicity. For example, tricyclic antidepressant drugs often cause anticholinergic effects and weight gain leading to premature discontinuation of therapy, and they can by lethal in overdose (a significant problem in depressed patients). Lithium is the augmentation strategy with the best published evidence of efficacy (although there are few published studies documenting long-term effectiveness), but lithium has a narrow therapeutic index that makes it difficult to administer; among the risks associated with lithium are renal and thyroid toxicity. Monoamine oxidase inhibitors are prone to produce an interaction with certain common foods that results in hypertensive crises. Even selective serotonin reuptake inhibitors can rarely produce fatal reaction in the form of a serotonin syndrome.
Physicians usually reserve ECT for treatment-resistant cases or when they determine a rapid response to treatment is desirable. ECT is also associated with significant risks: long-lasting cognitive impairment following ECT significantly limits the acceptability of ECT as a long-term treatment for depression. Therefore, there is a compelling unmet need for non-pharmacological well-tolerated and effective long-term or maintenance treatments for patients who do not respond fully, or for patients who do not sustain a response to first-line pharmacological therapies.
In some patients the beneficial effects of GMP may last for sometime. These patient's may be implanted with the nerve stimulator sometime after receiving their last dose of GMP therapy. This form of combination therapy, where a patient receives GMP therapy initially and sometime later receives pulsed electrical stimulation therapy, is also considered within the scope of the invention.
U.S. Pat. No. 5,879,299 (Posse) et al. is generally directed to method and system for providing prelocalization of a volume of interest and for rapidly acquiring a data set for generating spectroscopic images. Spectroscopic imaging data is acquired by an echo planar spatial-spectral imaging sequence in which the gradient reversal frequency is a integer factor of n greater than the gradient reversal frequency required to sample the spectral width. There is no disclosure or suggestion for providing any kind of therapy for neruopsychiatric disorders.
U.S. Pat. No. 6,572,528 B2 (Rohan et al.) and U.S. Patent Application No. U.S. 2004/0010177 A1 (Rohan et al.) is generally directed to magnetic field stimulation techniques. There is no disclosure or even suggestion for combining magnetic fields to the brain with electrical pulses to the vagus nerve to provide therapy for neuropsychiatric disorders.
U.S. Pat. No. 5,270,654 (Feinberg et al.) is generally directed to fast magnetic resonance imaging using combined gradient echoes and spin echoes. Again, there is no disclosure or suggestion for providing any kind of therapy for neruopsychiatric disorders.
U.S. Pat. No. 6,472,871 B2 (Ryner) is generally directed to generating a spectroscopic image using magnetic resonance for obtaining spectroscopic data from voxels by subjecting the sample to repeated magnetic resonance experiments.
U.S. Pat. No. 5,299,569 (Wernicke et al.) is directed to the use of implantable pulse generator technology for treating and controlling neuropsychiatric disorders including schizophrenia, depression, and borderline personality disorder.
U.S. Pat. No. 6,205,359 B1 (Boveja) and U.S. Pat. No. 6,356,788 B2 (Boveja) are directed to adjunct therapy for neurological and neuropsychiatric disorders using an implanted lead-receiver and an external stimulator.
Rohan M. et al., “Low-Field Magnetic Stimulation in Bipolar Depression Using an MRI-Based stimulator”. American Journal of Psychiatry, vol. 161: pp. 93-98, 2004.
A novel method for providing therapy or alleviating the symptoms of neuropsychiatric disorders and cognitive impairments comprises, providing gradient magnetic pulses (GMP) to the brain and afferent neuromodulation of the vagus nerve(s) (VN) with pulsed electrical stimulation. The combination of GMP and VN stimulation provides a more ideal combination for device based interventions, with or without concomitant drug therapy. In this novel method of therapy, GMP induces stimulation from the outside, and selective vagus nerve stimulation approaches the stimulation from inside the brain.
Accordingly in one aspect of the invention, method and system to provide therapy for or alleviate the symptoms of neuropsychiatric disorders and cognitive impairments comprises providing gradient magnetic pulses to the brain of a patient and afferent neuromodulation of a vagus nerve(s) with electrical pulses.
In another aspect of the invention, the combination of gradient magnetic pulses provided to the brain and electrical pulses provided to vagus nerve(s) are in any sequence or any combination, as determined by the physician.
In another aspect of the invention, the gradient magnetic pulses have a frequency of about 1 kHz and produce electric fields of the same frequency.
In another aspect of the invention, the gradient magnetic pulses to the brain can be provided by an echo-planer magnetic resonance spectroscopic imaging (EP-MRSI) system, among other systems.
In another aspect of the invention, the gradient magnetic pulses induce relatively uniform electric fields in the brain with an amplitude of between 1 V/m and 100 V/m.
In another aspect of the invention, the afferent modulation of the vagus nerve(s) is by providing electric pulses at any point along the length said vagus nerve(s).
In another aspect of the invention, the vagus nerve(s) is/are neuromodulated bilaterally.
In another aspect of the invention, the system to provide electrical pulses to the vagus nerve(s) has both implanted and external components, and may be one selected from the following group: a) an implanted stimulus-receiver with an external stimulator; b) an implanted stimulus-receiver comprising a high value capacitor for storing charge, used in conjunction with an external stimulator; c) a programmer-less implantable pulse generator (IPG) which is operable with a magnet; d) a programmable implantable pulse generator (IPG); e) a combination implantable device comprising both a stimulus-receiver and a programmable IPG; and f) an IPG comprising a rechargeable battery.
In yet another aspect of the invention, the system for providing electrical pulses to the vagus nerve(s) can be remotely interrogated or remotely programmed over a wide area network, either wirelessly or over land-lines.
Various other features, objects and advantages of the invention will be made apparent from the following description taken together with the drawings.
For the purpose of illustrating the invention, there are shown in accompanying drawing forms which are presently preferred, it being understood that the invention is not intended to be limited to the precise arrangement and instrumentalities shown.
FIGS. 29 is a simplified diagram showing communication of modified PDA/phone, with an external stimulator via a cellular tower/base station.
In the method and system of this invention, magnetic and electric fields are applied to the whole brain and electrical pulses are delivered to the vagus nerve(s), for treating or alleviating the symptoms of neuropsychiatric disorders and cognitive impairments. These disorders include depression, bipolar depression, anxiety disorders, obsessive-compulsive disorders, schizophrenia, borderline personality disorders, sleep disorders, learning difficulties, memory impairments and the like. This stimulation therapy may be used as adjunct (add-on) therapy. The magnetic and electric fields to the whole brain may be supplied using an echo-planer magnetic resonance spectroscopic imaging (EP-MRSI) device, or any other appropriate device for delivering gradient magnetic pulses of appropriate characteristics. Pulsed electrical stimulation to the vagus nerve(s) 54 is supplied using a pulse generator means and a lead with electrodes in contact with nerve tissue. The two stimulation therapies may be applied in any combination or sequence. The whole brain magnetic and electric fields (
Advantageously, the two types of stimulations approach the relevant centers in the brain via different approaches. With GMP the approach is via uniformly distributed magnetic fields leading to electrical fields from the outside, and with vagus nerve(s) 54 pulsed electrical stimulation, the approach to centers in the brain is from the inside (
As mentioned previously, any combination or sequence of these two energies may be applied, and is determined by the physician for each patient.
One prior art (U.S. Pat. No. 6,572,528 B2) system for providing gradient magnetic pulses is shown in conjunction with
∇xE(x, y, z, t)=−∂B(x, y, z, t)/∂t, where ∇xE is the curl of the electric field, and ∂B/∂t is the rate of change of the magnetic field over time. In Cartesian coordinates, this equation becomes:
∂E x /∂y−∂E y /∂x=−∂B z /∂t,
∂E y /∂z−∂E z /∂y=−∂B x /∂t,
∂E z /∂x−∂E x /∂x=−∂B x /∂t,
One techniques to deliver gradient magnetic pulses is magnetic resonance spectroscopic imaging (MRSI). This technique is incorporated in this application and is one method to provide gradient magnetic pulses in one embodiment. Other systems in development, or developed in the future to provide gradient magnetic pulses can also be used in conjunction with VNS therapy for the purpose of this invention, and are within the scope of this invention.
Spectroscopic imaging techniques have been developed which combine magnetic resonance imaging (MRI) techniques with nuclear magnetic resonance (NMR) spectroscopic techniques, thus providing a spatial image of the chemical composition. There has been increasing interest in the study of brain metabolism using proton MR spectroscopy and spectroscopic imaging because of its noninvasive assessment of regional biochemistry.
Shown in conjunction with
Gradient generators 202, 204, and 206, which include respective gradient coils, produce the Gx, Gy, and Gz magnetic fields in the direction of the polarizing magnetic field Bo, but with gradients directed in the x, y, and z directions, respectively. The use of the Gx, Gy, and Gz are well known in the art, including such uses as dephasing or rephasing excited spins, spatial phase encoding or spatial gradient encoding acquired signals, and spatial encoding of the Larmor frequency of nuclei for slice selection. Induced nuclear magnetic resonance signals are detected by receiver coils in the magnet (not shown). The receiver coils and the transmitter coils may be the same, with a transmit/receive (T/R) switch being used to select transmission or reception of radio frequency signals to or from the coils, respectively. The received signal is demodulated by demodulator 210, and the demodulated signal is amplified and processed in the analog-to-digital processing unit 212 to provide data as indicated at 214. The entire process is monitored and controlled by the processor means 220 which, according to the functional block diagram of
Gradient magnetic energy is typically applied for approximately 20 minutes per session, but may vary at the discretion of the physician. EP-MRSI employs oscillating magnetic fields that are similar to those used in functional magnetic resonance imaging (fMRI) but that differ from the usual fMRI scan in field direction, waveform frequency, and strength. The characteristics of the electromagnetic fields of EP-MRSI can be further illustrated by comparing the fields of EP-MRSI with those of well known repetitive transcranial magnetic stimulation (rTMS). EP-MRSI and rTMS both subject the brain to time-varying magnetic and electric fields. The fields in the EP-MRSI are very different from those in rTMS in strength, uniformity, direction, and timing. It is noteworthy that the EP-MRSI fields are 100 to 1,000 times weaker than the rTMS fields, penetrate throughout the whole brain, and are delivered at 1 kHz. The EP-MRSI magnetic field of interest is the readout gradient. This magnetic field is delivered in a series of 512 trapezoid pulses that are each 1 msec long, as shown in
In contrast, shown in conjunction with
The uniformity, unidirectionality, and whole-brain penetration of the EP-MRSI treatment may be selecting very different structures in the brain, compared with the well known rTMS. It is hypothesized that the right-to-left electric fields in EP-MRSI could be selecting corpus callosum, whose axons lie in that direction. The corpus callosum is a broad band of neurons connecting the right and left hemispheres, and is shown in
As shown in conjunction with
Electrical pulses are provided to the vagus nerve(s) 54 using a system that comprises both implantable and external components. The system to provide selective stimulation may be selected from one of the following:
The pulse generator means is in electrical contact with a lead, which is adapted to be in contact with the vagus nerve(s) or its branches. The pulse generator/stimulator can be of any form or type including those that are in current use or in development or to be developed in future. U.S. Pat. Nos. 4,702,254, 5,025,807, and 5,154,172 (Zabara) describe pulse generator and associated software to provide VNS therapy which are also included here by reference, in this invention for application of VNS.
Using any of these systems, selective pulsed electrical stimulation is applied to vagus nerve(s) for afferent neuromodulation, at any point along the length of the nerve. The waveform of electrical pulses is shown in
These stimulation systems for vagus nerve modulation are more fully described in a co-pending application (Ser. No. 10/841,995), but are mentioned here briefly for convenience. In each case, an implantalbe lead is surgically implanted in the patient 32. The vagus nerve(s) is/are surgically exposed and isolated. The electrodes on the distal end of the lead are wrapped around the vagus nerve(s) 54, and the lead is tunneled subcutaneously. A pulse generator means is connected to the proximal end of the lead. The power source may be external, implantable, or a combination device.
For utilizing an external power source, a passive implanted stimulus-receiver may be used. This embodiment of the vagus nerve pulse generator means is shown in conjunction with
The carrier frequency is optimized. One preferred embodiment utilizes electrical signals of around 1 Mega-Hertz, even though other frequencies can be used. Low frequencies are generally not suitable because of energy requirements for longer wavelengths, whereas higher frequencies are absorbed by the tissues and are converted to heat, which again results in power losses.
Shown in conjunction with
Shown in conjunction with
For therapy to commence, the primary (external) coil 46 is placed on the skin 60 on top of the surgically implanted (secondary) coil 48. An adhesive tape may be placed on the skin 60 and external coil 46 such that the external coil 46, is taped to the skin 60. For efficient energy transfer to occur, it is important that the primary (external) 46 and secondary (internal) coils 48 be positioned along the same axis and be optimally positioned relative to each other. In this embodiment, the external coil 46 may be connected to proximity sensing circuitry 50, in which case the correct positioning of the external coil 46 with respect to the internal coil 48 is indicated by turning “on” of a light emitting diode (LED) on the external stimulator 42.
The programmable parameters are stored in a programmable logic in the external stimulator 42. The predetermined programs stored in the external stimulator 42 are capable of being modified through the use of a separate programming station 77. A Programmable Array Logic Unit and interface unit are interfaced to the programming station 77. The programming station 77 can be used to load new programs, change the existing predetermined programs or the program parameters for various stimulation programs. The programming station is connected to the programmable array unit (comprising programmable array logic and interface unit) with an RS232-C serial connection. The main purpose of the serial line interface is to provide an RS232-C standard interface. Other well known interface connections may also be used.
This method enables any portable computer with a serial interface to communicate and program the parameters for storing the various programs. The serial communication interface receives the serial data, buffers this data and converts it to a 16 bit parallel data. The programmable array logic component of programmable array unit (not shown) receives the parallel data bus and stores or modifies the data into a random access matrix. This array of data also contains special logic and instructions along with the actual data. These special instructions also provide an algorithm for storing, updating and retrieving the parameters from long-term memory. The programmable logic array unit, interfaces with long term memory to store the predetermined programs. All the previously modified programs can be stored here for access at any time, as well as, additional programs can be locked out for the patient. The programs consist of specific parameters and each unique program will be stored sequentially in long-term memory. A battery unit is present to provide power to all the components. The logic for the storage and decoding is stored in a random addressable storage matrix (RASM).
Conventional microprocessor and integrated circuits are used for the logic, control and timing circuits. Conventional bipolar transistors are used in radio-frequency oscillator, pulse amplitude ramp control and power amplifier. A standard voltage regulator is used in low-voltage detector. The hardware and software to deliver the pre-determined programs is well known to those skilled in the art.
The selective stimulation of the vagus nerve(s) can be performed in one of two ways. One method is to activate one of several “pre-determined/pre-packaged” programs. A second method is to “custom” program the electrical parameters, which can be selectively programmed for specific therapy to the individual patient. The electrical parameters that can be individually programmed, include variables such as pulse amplitude, pulse width, frequency of stimulation, stimulation on-time, and stimulation off-time. Table one below defines the approximate range of parameters,
TABLE 1 Electrical parameter range delivered to the nerve PARAMER RANGE Pulse Amplitude 0.1 Volt-10 Volts Pulse width 20 μS-5 mSec. Frequency 5 Hz-200 Hz On-time 10 Secs-24 hours Off-time 10 Secs-24 hours
The parameters in Table 1 are the electrical signals delivered to the nerve via the two electrodes 61,62 (distal and proximal) around the nerve, as shown in
TABLE 2 Lead design variables Proximal Distal End End Conductor (connecting Lead body- proximal Lead Insulation and distal Electrode - Electrode - Terminal Materials Lead-Coating ends) Material Type Linear Polyurethane Antimicrobial Alloy of Pure Spiral bipolar coating Nickel- Platinum electrode Cobalt Bifurcated Silicone Anti- Platinum- Wrap-around Inflammatory Iridium electrode coating (Pt/lr) Alloy Silicone with Lubricious Pt/lr coated Steroid Polytetrafluoro- coating with Titanium eluting ethylene Nitride (PTFE) Carbon Hydrogel electrodes Cuff electrodes
Once the lead is fabricated, coating such as anti-microbial, anti-inflammatory, or lubricious coating may be applied to the lead body 59.
In one embodiment, the implanted stimulus-receiver may be a system which is RF coupled combined with a power source. In this embodiment, the implanted stimulus-receiver comprises high value, small sized capacitor(s) for storing charge and delivering electric stimulation pulses for up to several hours by itself, once the capacitors are charged. The packaging is shown in
As shown in conjunction with
The refresh-recharge transmitter unit 460 includes a primary battery 426, an ON/Off switch 427, a transmitter electronic module 424, an RF inductor power coil 46A, a modulator/demodulator 420 and an antenna 422.
When the ON/OFF switch is on, the primary coil 46A is placed in close proximity to skin 60 and secondary coil 48A of the implanted stimulator 490. The inductor coil 46A emits RF waves establishing EMF wave fronts which are received by secondary inductor 48A. Further, transmitter electronic module 424 sends out command signals which are converted by modulator/demodulator decoder 420 and sent via antenna 422 to antenna 418 in the implanted stimulator 490. These received command signals are demodulated by decoder 416 and replied and responded to, based on a program in memory 414 (matched against a “command table” in the memory). Memory 414 then activates the proper controls and the inductor receiver coil 48A accepts the RF coupled power from inductor 46A.
The RF coupled power, which is alternating or AC in nature, is converted by the rectifier 408 into a high DC voltage. Small value capacitor 406 operates to filter and level this high DC voltage at a certain level. Voltage regulator 402 converts the high DC voltage to a lower precise DC voltage while capacitive power source 400 refreshes and replenishes.
When the voltage in capacative source 400 reaches a predetermined level (that is VDD reaches a certain predetermined high level), the high threshold comparator 430 fires and stimulating electronic module 412 sends an appropriate command signal to modulator/decoder 416. Modulator/decoder 416 then sends an appropriate “fully charged” signal indicating that capacitive power source 400 is fully charged, is received by antenna 422 in the refresh-recharge transmitter unit 460.
In one mode of operation, the patient may start or stop stimulation by waving the magnet 442 once near the implant. The magnet emits a magnetic force Lm which pulls reed switch 410 closed. Upon closure of reed switch 410, stimulating electronic module 412 in conjunction with memory 414 begins the delivery (or cessation as the case may be) of controlled electronic stimulation pulses to the vagus nerve(s) 54 via electrodes 61, 62. In another mode (AUTO), the stimulation is automatically delivered to the implanted lead based upon programmed ON/OFF times.
The programmer unit 450 includes keyboard 432, programming circuit 438, rechargeable battery 436, and display 434. The physician or medical technician programs programming unit 450 via keyboard 432. This program regarding the frequency, pulse width, modulation program, ON time etc. is stored in programming circuit 438. The programming unit 450 must be placed relatively close to the implanted stimulator 490 in order to transfer the commands and programming information from antenna 440 to antenna 418. Upon receipt of this programming data, modulator/demodulator and decoder 416 decodes and conditions these signals, and the digital programming information is captured by memory 414. This digital programming information is further processed by stimulating electronic-module 412. In the DEMAND operating mode, after programming the implanted stimulator, the patient turns ON and OFF the implanted stimulator via hand held magnet 442 and the reed switch 410. In the automatic mode (AUTO), the implanted stimulator turns ON and OFF automatically according to the programmed values for the ON and OFF times.
Other simplified versions of such a system may also be used. For example, a system such as this, where a separate programmer is eliminated, and simplified programming is performed with a magnet and reed switch, can also be used.
In one embodiment, a programmer-less implantable pulse generator (IPG) may be used. In this embodiment, shown in conjunction with
In one embodiment, shown in conjunction with
Once the prepackaged/predetermined logic state is activated by the logic and control circuit 102, the pulse generation and amplification circuit 106 deliver the appropriate electrical pulses to the vagus nerve(s) 54 of the patient via an output buffer 108 (as shown in
In one embodiment, there are four stimulation states. A larger (or lower) number of states can be achieved using the same methodology, and such is considered within the scope of the invention. These four states are, LOW stimulation state, LOW-MED stimulation state, MED stimulation state, and HIGH stimulation state. Examples of stimulation parameters (delivered to the vagus nerve) for each state are as follows,
LOW stimulation state example is,
Current output: 0.75 milliAmps. Pulse width: 0.20 msec. Pulse frequency: 20 Hz Cycles: 20 sec. on-time and 2.0 min. off-time in repeating cycles.
LOW-MED stimulation state example is,
Current output: 1.5 milliAmps, Pulse width: 0.30 msec. Pulse frequency: 25 Hz Cycles: 1.5 min. on-time and 20.0 min. off-time in repeating cycles.
MED stimulation state example is,
Current output: 2.0 milliAmps. Pulse width: 0.30 msec. Pulse frequency: 30 Hz Cycles: 1.5 min. on-time and 20.0 min. off-time in repeating cycles.
HIGH stimulation state example is,
Current output: 3.0 milliAmps, Pulse width: 0.40 msec. Pulse frequency: 30 Hz Cycles: 2.0 min. on-time and 20.0 min. off-time in repeating cycles.
These prepackaged/predetermined programs are mearly examples, and the actual stimulation parameters will deviate from these depending on the patient or treatment application.
It will be readily apparent to one skilled in the art, that other schemes can be used for the same purpose. For example, instead of placing the magnet 90 on the pulse generator 171 for a prolonged period of time, different stimulation states can be encoded by the sequence of magnet applications. Accordingly, in an alternative embodiment there can be three logic states, OFF, LOW stimulation (LS) state, and HIGH stimulation (HS) state. Each logic state again corresponds to a prepackaged/predetermined program such as presented above. In such an embodiment, the system could be configured such that one application of the magnet 90 triggers the generator into LS State. If the generator is already in the LS state then one application triggers the device into OFF State. Two successive magnet applications triggers the generator into MED stimulation state, and three successive magnet applications triggers the pulse generator in the HIGH Stimulation State. Subsequently, one application of the magnet while the device is in any stimulation state, turns the device OFF.
The advantage of this embodiment is that it is cheaper to manufacture than a fully programmable implantable pulse generator (IPG).
In one embodiment, a fully programmable implantable pulse generator (IPG) may be used. Shown in conjunction with
This embodiment may also comprise optional fixed pre-determined/pre-packaged programs. Examples of LOW, LOW-MED, MED, and HIGH stimulation states were given in the previous section, under “Programmer-less Implantable Pulse Generator (IPG)”. These pre-packaged/pre-determined programs comprise unique combinations of pulse amplitude, pulse width, pulse frequency, ON-time and OFF-time. Advantageously, a number of these “pre-determined/pre-packaged programs” may be stored in a “library”, and activated in a simple fashion, without having to program each parameter individually.
In addition, each parameter may be individually programmed and stored in memory. The range of programmable electrical stimulation parameters are shown in table 3 below.
TABLE 3 Programmable electrical parameter range PARAMER RANGE Pulse Amplitude 0.1 Volt-10 Volts Pulse width 20 μS-5 mSec. Frequency 3 Hz-300 Hz On-time 5 Secs-24 hours Off-time 5 Secs-24 hours Ramp ON/OFF
Shown in conjunction with
Most of the digital functional circuitry 350 is on a single chip (IC). This monolithic chip along with other IC's and components such as capacitors and the input protection diodes are assembled together on a hybrid circuit. As well known in the art, hybrid technology is used to establish the connections between the circuit and the other passive components. The integrated circuit is hermetically encapsulated in a chip carrier. A coil 399 situated under the hybrid substrate is used for bidirectional telemetry. The hybrid and battery 397 are encased in a titanium can. This housing is a two-part titanium capsule that is hermetically sealed by laser welding. Alternatively, electron-beam welding can also be used. The header 79 is a cast epoxy-resin with hermetically sealed feed-through, and form the lead 40 connection block.
In one embodiment, the implantable device may comprise both a stimulus-receiver and a programmable implantable pulse generator (IPG).
Shown in conjunction with
With reference to
Again with reference to
As shown in conjunction with
In one embodiment, an implantable pulse generator with rechargeable power source can be used. In such an embodiment (shown in conjunction with
In summary, in the method of the current invention for neuromodulation of cranial nerve such as the vagus nerve(s), to provide therapy for psychiatric disorders, neuropsychiatric disorders and cognitive impairments, can be practiced with any of the several pulse generator systems disclosed including,
Neuromodulation of vagus nerve(s) with any of these systems is considered within the scope of this invention.
In one embodiment, the external stimulator and/or the programmer has a telecommunications module, as described in a co-pending application, and summarized here for reader convenience. The telecommunications module has two-way communications capabilities.
In one aspect of the invention, the telecommunications component can use Wireless Application Protocol (WAP), which is a set of communication protocols standardizing Internet access for wireless devices. While previously, manufacturers used different technologies to get Internet on hand-held devices, with WAP devices and services interoperate. WAP also promotes convergence of wireless data and the Internet. The WAP programming model is heavily based on the existing Internet programming model. Introducing a gateway function provides a mechanism for optimizing and extending this model to match the characteristics of the wireless environment. Over-the-air traffic is minimized by binary encoding/decoding of Web pages and readapting the Internet Protocol stack to accommodate the unique characteristics of a wireless medium such as call drops.
In one aspect, the server initiates an upload of the actual parameters being applied to the patient, receives these from the stimulator, and stores these in its memory, accessible to the authorized user as a dedicated content driven web page. The physician or authorized user can make alterations to the actual parameters, as available on the server, and then initiate a communication session with the stimulator device 42 to download these parameters.
Shown in conjunction with
The telemetry module 362 comprises an RF telemetry antenna coupled to a telemetry transceiver and antenna driver circuit board which includes a telemetry transmitter and telemetry receiver. The telemetry transmitter and receiver are coupled to control circuitry and registers, operated under the control of microprocessor 364. Similarly, within stimulator a telemetry antenna is coupled to a telemetry transceiver comprising RF telemetry transmitter and receiver circuit. This circuit is coupled to control circuitry and registers operated under the control of microcomputer circuit.
With reference to the telecommunications aspects of the invention, the communication and data exchange between Modified PDA/Phone 502 and external stimulator 42 operates on commercially available frequency bands. The 2.4-to-2.4853 GHz bands or 5.15 and 5.825 GHz, are the two unlicensed areas of the spectrum, and set aside for industrial, scientific, and medical (ISM) uses. Most of the technology today including this invention, use either the 2.4 or 5 GHz radio bands and spread-spectrum technology.
Shown in conjunction with
The standard components of interface unit shown in block 292 are processor 305, storage 310, memory 308, transmitter/receiver 306, and a communication device such as network interface card or modem 312. In the preferred embodiment these components are embedded in the external stimulator 42 and can also be embedded in the programmer 85. These can be connected to the network 290 through appropriate security measures (Firewall) 293.
Another type of remote unit that may be accessed via central collaborative network 290 is remote computer 294. This remote computer 294 may be used by an appropriate attending physician to instruct or interact with interface unit 292, for example, instructing interface unit 292 to send instruction downloaded from central computer 286 to remote implanted unit 75.
The telecommunications technology, especially the wireless internet technology, which this invention utilizes in one embodiment, is constantly improving and evolving at a rapid pace, due to advances in RF and chip technology as well as software development. Therefore, one of the intents of this invention is to utilize “state of the art” technology available for data communication between Modified PDA/Phone 502 and external stimulator 42. The intent of this invention is to use “3 G” or above versions of technology for wireless communication and data exchange, even though in some cases “2.5 G” is being used currently.
For the system of the current invention, the use of any of the “3 G” technologies for communication for the Modified PDA/Phone 502, is considered within the scope of the invention. Further, it will be evident to one of ordinary skill in the art that as future “4 G” systems, which will include new technologies such as improved modulation and smart antennas, can be easily incorporated into the system and method of current invention, and are also considered within the scope of the invention.
The present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. It is therefore desired that the present embodiment be considered in all aspects as illustrative and not restrictive, reference being made to the appended claims rather than to the foregoing description to indicate the scope of the invention.
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|Cooperative Classification||A61N1/36082, A61N2/006, A61N1/36114|
|European Classification||A61N1/36Z, A61N1/36Z3E, A61N2/00T2|